A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
NCT ID: NCT00099177
Last Updated: 2017-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
96 participants
INTERVENTIONAL
2005-08-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
ibandronate [Bondronat]
6mg iv on days 1-3, and 50mg po from day 22 to week 24
2
zoledronic acid
4mg iv on day 1, and every 3-4 weeks
Interventions
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ibandronate [Bondronat]
6mg iv on days 1-3, and 50mg po from day 22 to week 24
zoledronic acid
4mg iv on day 1, and every 3-4 weeks
Eligibility Criteria
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Inclusion Criteria
* patients with moderate to severe pain.
Exclusion Criteria
* patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
* untreated esophagitis or gastric ulcers;
* recent or pre-scheduled radiotherapy to bone;
* patients who are pregnant or breast-feeding.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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La Paz, , Mexico
Mexicali, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Panama City, , Panama
Poznan, , Poland
Poznan, , Poland
San Juan, , Puerto Rico
Kazan', , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Obninsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Sankt Gallen, , Switzerland
Manchester, , United Kingdom
Sutton, , United Kingdom
Miami, Florida, United States
Macon, Georgia, United States
Houston, Texas, United States
Bahía Blanca, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
Santa Fe, , Argentina
Adelaide, , Australia
Brisbane, , Australia
Santiago, , Chile
Viña del Mar, , Chile
Hamburg, , Germany
Kalyftaki Kifissia, , Greece
Thessaloniki, , Greece
Guatemala City, , Guatemala
Budapest, , Hungary
Budapest, , Hungary
Deszk, , Hungary
Szeged, , Hungary
Rozzano, , Italy
Torino, , Italy
Countries
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Other Identifiers
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BO18039
Identifier Type: -
Identifier Source: org_study_id
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